Patch pump cartridge attachment

ABSTRACT

A user-wearable patch pump system for delivery of insulin or other medicament can include a patch pump having a reusable drive unit and a replaceable and refillable cartridge. The cartridge can selectively attach to and be detached from the drive unit. The cartridge can initially be inserted onto the drive unit in a first orientation at an angle to the drive unit and then be rotated to align the cartridge with the drive unit and lock the cartridge in place on the drive unit to form the patch pump.

RELATED APPLICATION

This application is a continuation of application Ser. No. 15/158,125filed May 18, 2016, which claims the benefit of U.S. ProvisionalApplication No. 62/163,158 filed May 18, 2015, each of which is herebyincorporated herein in its entirety by reference.

FIELD OF THE INVENTION

The present invention relates to medical pumps for delivering medicamentto a patient and, more specifically, to a user-wearable insulin patchpump for delivering insulin to a patient.

BACKGROUND OF THE INVENTION

There are many applications in academic, industrial, and medical fieldsthat benefit from devices and methods that are capable of accurately andcontrollably delivering fluids, such as liquids and gases, that have abeneficial effect when administered in known and controlled quantities.Such devices and methods can be particularly useful in the medical fieldwhere treatments for many patients include the administration of a knownamount of a substance at predetermined intervals.

One category of devices for delivering such fluids is that of pumps thathave been developed for the administration of insulin and othermedicaments for those suffering from both type I and type II diabetes.Some pumps configured as portable infusion devices can providecontinuous subcutaneous medicament injection and/or infusion therapy forthe treatment of diabetes. Such therapy may include, e.g., the regularand/or continuous injection or infusion of insulin into the skin of aperson suffering from diabetes and offer an alternative to multipledaily injections of insulin by an insulin syringe or an insulin pen.Such pumps can be ambulatory/portable infusion pumps that are worn bythe user and may use replaceable cartridges. Examples of such pumps andvarious features that can be associated with such pumps include thosedisclosed in U.S. Patent Application Publication No. 2013/0053816, U.S.Pat. No. 8,573,027, U.S. Pat. No. 8,986,253, U.S. Patent ApplicationPublication No. 2013/0324928, U.S. Patent Application Publication No.2013/0331790 and U.S. Pat. No. 8,287,495, each of which is herebyincorporated herein by reference in its entirety.

One type of pump that has been developed is a patch pump, or micro pump.Patch pumps are small pumps, typically ambulatory, that are carrieddirectly on the skin under the user's clothing. Many such pumps aresituated directly on the injection site such that no tubing is requiredto deliver the insulin or other medicament to the patient. Other patchpumps can be positioned on the user's body with a short length of tubingextending to a nearby infusion site. Patch pumps typically are at leastin part disposable, meant to be worn for a day or two and then discardedfor a new patch pump.

BRIEF DESCRIPTION OF THE DRAWINGS

Subject matter hereof may be more completely understood in considerationof the following detailed description of various embodiments inconnection with the accompanying figures, in which:

FIGS. 1A-1F are views of portions of a patch pump system according to anembodiment of the present invention.

FIGS. 2A-2C depict a cartridge being attached to a drive unit of a patchpump system according to an embodiment of the present invention.

FIGS. 3A-3D are schematic representations of a cartridge and drivemechanism of a patch pump system according to an embodiment of thepresent invention.

FIGS. 4A-4B, 5A-5B and 6A-6B depict alternate uses of a patch pumpaccording to an embodiment of the present inventions.

FIGS. 7A-7C depicts remote control devices for a patch pump systemaccording to embodiments of the present invention.

FIG. 8 depicts a patch pump system according to an embodiment of thepresent invention.

FIGS. 9A-9D depict a procedure for filling a cartridge of a patch pumpsystem according to an embodiment of the present invention.

FIGS. 10A-10E depict a procedure for inductively charging the battery ofa patch pump system according to an embodiment of the present invention.

FIGS. 11A-11E depict a procedure for inserting a cannula into the skinof a user of a patch pump system according to an embodiment of thepresent invention.

FIGS. 12A-12D depict a procedure for inserting a cannula into the skinof a user of a patch pump system according to an embodiment of thepresent invention.

FIGS. 13A-13C depict a patch pump according to an embodiment of thepresent invention.

FIGS. 14A-14B depict a patch pump system according to an embodiment ofthe present invention.

FIGS. 15-16, 17A-17B, 18A-18C and 19 are schematic representations of acartridge and drive mechanism of a patch pump system according to anembodiment of the present invention.

While various embodiments are amenable to various modifications andalternative forms, specifics thereof have been shown by way of examplein the drawings and will be described in detail. It should beunderstood, however, that the intention is not to limit the claimedinventions to the particular embodiments described. On the contrary, theintention is to cover all modifications, equivalents, and alternativesfalling within the spirit and scope of the subject matter as defined bythe claims.

SUMMARY

A user-wearable patch pump system for delivery of insulin or othermedicament can include a patch pump having a reusable drive unit and areplaceable and/or refillable cartridge. The cartridge can selectivelyattach to and be detached from the drive unit. The cartridge caninitially be inserted onto the drive unit in a first orientation at anangle to the drive unit and then be rotated to align the cartridge withthe drive unit and lock the cartridge in place on the drive unit to formthe patch pump.

In some embodiments a user-wearable infusion pump system includes a pumphaving a disposable cartridge and a drive unit. The disposable cartridgecan be configured to contain a medicament and include a cartridgehousing having a front surface and a rear surface and a coupling recessdefined in a bottom surface of the cartridge housing. The drive unit canbe configured to cause medicament in the cartridge to be delivered to auser wearing the pump and include a drive unit housing having a frontsurface and a rear surface and a drive mechanism having a drive endextending from the drive unit. The coupling recess in the cartridge canbe configured to be inserted onto the drive end of the drive mechanismwith the cartridge in a first orientation with respect to the drive unitand the cartridge can be configured to then be rotated with respect tothe drive unit in a first direction with the drive end in the couplingrecess to lock the cartridge onto the drive unit in a second orientationwith the front surface of the cartridge aligned generally parallel withthe front surface of the drive unit. In various embodiments, the anglebetween the cartridge and drive unit can be between about 30 degrees andabout 150 degrees, including for example, a generally perpendicular(about 90 degree angle) and about a 60 degree angle.

In some embodiments, the cartridge includes a pair of flanges onopposing sides of the coupling recess each adjacent a respective slotand the drive end includes a pair of threads on opposing sides of thedrive end. The flanges, slots and threads cooperate to lock thecartridge onto the drive unit in the second orientation with each threadseating in a respective one of the slots. The flanges can be positionedaxially proximally in the coupling recess with respect to the slots; thecartridge is rotated from the first orientation to the secondorientation by inserting the cartridge onto the drive end to axiallyadvance the threads past the flanges to align the threads with the slotsand by rotating the cartridge to seat the threads in the slots.

In such embodiments, flanges in coupling recess serve the dual purposeof ensuring proper angular orientation and axial insertion depth of thecartridge for the connection, in addition to aiding in retaining thecartridge on the drive unit once it is connected. If the threads on thedrive end and the flanges in the coupling recess are positioned suchthat the threads are rotationally aligned with the flanges, the flangeswill prevent the threads from being axially advanced past the flanges,requiring a proper angular orientation of the cartridge with respect tothe drive unit to reach the proper insertion depth. In addition, if thecartridge is rotated for the connection prior to reaching that properaxial insertion depth, the flanges in the coupling recess instead willbe axially aligned with the threads on the drive unit, such that thethreads will inhibit rotation of the cartridge by abutting the flanges,thus preventing connection of the cartridge to the drive unit. In someembodiments, the threads and flanges can include corresponding concaveand convex or otherwise mating surfaces, respectively, that interfacewith each other to prevent excess wear on the components due to suchinteractions.

In such embodiments, the slots in the cartridge recess and thecorresponding threads on the drive mechanism can have additionalcomplementary features to ensure a strong and reliable coupling of thecartridge to the drive unit. The threads can, for instance, includedetent projections that nest into detent grooves in the slots when thecartridge has been rotated to seat the threads in the slots and providetactile and even audible feedback to the user to confirm a secure andproper connection. These detents help prevent the cartridge from freelyrotating with respect to the drive unit while still enabling thecartridge to be rotated in the opposite direction to disconnect thecartridge from the drive unit if a required amount of rotational forceis applied. The threads can also increase in width from a leading edgeof the threads that first enters the slots as the cartridge is rotatedto provide a secure compression fit between the threads and the slots.The above summary is not intended to describe each illustratedembodiment or every implementation of the subject matter hereof. Thefigures and the detailed description that follow more particularlyexemplify various embodiments.

DETAILED DESCRIPTION

FIGS. 1A-1F depict a patch pump 100 including a pump 102 and anattachment portion 104 according to an embodiment of the invention.Patch pump 100 does not include a built-in display or user interface,and is therefore primarily remote controlled. Retention frame 106 ofattachment portion 104 includes an insertion portion 112 through which adisposable needle can be inserted to penetrate a sealing membrane andinsert a cannula for medicament delivery. Reusable drive unit 118 ofpump includes a drive mechanism 122 that mates with a recess 124 indisposable cartridge 116 to attach the cartridge 116 to the drive unit118 and provide for delivery of medicament such as insulin from thecartridge 116 to a user through the cannula.

Retention frame 106 in this embodiment includes a hook portion 114adjacent one end of the frame and a snap portion 115 adjacent anopposing end of the frame. To mate the pump 102 with the correspondingattachment portion 104, initially hook portion 114 on retention frame106 is inserted, or hooked, into a recess 138 in the drive unit 118, asshown in FIGS. 1C and 1D. To complete the insertion and mating process,the pump 102 is pivoted downwardly about the hook portion 114 to mate arecess 139 in cartridge 116 with snap portion 115, as shown in FIGS. 1Eand 1F. Snap portion 115 can be flexible and resilient such that whenthe cartridge 116 is mated with the snap portion 115, the snap portion115 is initially pushed away from the pump 102 and then snaps into placewhen aligned with the recess 139 to cause an audible clicking orsnapping sound that provides an indication to the user that the pump 102is properly mated to the attachment portion 106. Pump 102 can bereleased from attachment portion 104 to, for example, enable a user toexchange the cartridge, with one or more tabs 136, which can bedepressed to cause one or both of hook portion 114 and snap portion 115to withdraw from its corresponding recess in pump 102.

In one embodiment, and as shown in FIGS. 2A-2C, cartridge 116 of pump102 can attach to drive unit 118 with a quarter turn attachment. Recess124 of cartridge 116 can be configured to initially attach to drivemechanism 122 of drive unit 118 such that an outer front housing surface840 of the cartridge 116 is offset from an outer front housing surface142 of the drive unit 818 at an angle of, e.g., about 90 degrees(generally perpendicular). The cartridge 116 can then be rotated towardthe drive unit 118 a quarter-turn to align the outer surface 140 of thecartridge 116 generally parallel with the outer surface 142 of the driveunit 118 and secure the cartridge 116 on the drive unit 118. In oneembodiment, the engagement of the cartridge 116 to the drive unit 118made by this rotation can cause an audible clicking sound that providesan auditory indication to the user that the cartridge is properlyattached by the use of, e.g., detent projections and grooves describedherein. Such a feature can alternatively or additionally provide atactile indication to the user that the cartridge is properly attached.

FIGS. 3A-3D depict further detail regarding such a cartridge 116attachment. In these figures, a housing of the drive unit 118 is notshown and only the drive mechanism 122 is depicted for sake of clarity.Cartridge 116 can include a pair of opposing flanges 160 adjacent recess124, which can be comprised of a flexible material. Cartridge 116 canalso include one or more detent projections 162, with two such detentprojections 162 depicted in this embodiment. The drive mechanism 122 caninclude one or more detent grooves 164 corresponding to the detentprojections 162 on the cartridge, although alternatively the drivemechanism 122 could include the projections and the cartridge 116 couldinclude the grooves. The drive mechanism 122 can also include one ormore partial turn threads 166, with this embodiment including a pair ofquarter-turn threads on opposing sides of the mechanism.

To engage the cartridge 116 with the drive mechanism 122, the drive end123 of the drive mechanism 122 can be inserted into the recess 124 ofthe cartridge 116 with the quarter-turn threads 166 of the drivemechanism 122 offset from the flanges 160 of the cartridge 116, as shownin FIG. 3A. This enables the quarter-turn threads 166 to be insertedinto the recess 124 past the flanges 160 so that when the cartridge 116is rotated into alignment with the drive unit 118, the quarter-turnthreads 166 and the flanges 160 align with and axially abut and/or alignwith each other to prevent the threads 166 from being withdrawn backthrough the recess 124. Therefore, interference between the quarter-turnthreads 166 and the flanges 160 will prevent the cartridge 116 frombeing pulled directly off of the drive mechanism 122 in this alignment,keeping the cartridge rigidly affixed to the drive mechanism 122. Inaddition, the detent projections 162 on the cartridge 116 nest into thedetent grooves 164 in the drive mechanism 122 at the completion of thequarter-turn rotation. This prevents the cartridge 116 from freelyrotating out of alignment with the drive unit 118, and correspondinglythe flanges 160 from freely rotating out of alignment with thequarter-turn threads 166, while still enabling such rotation if arequired amount of rotational force is applied. Although described as a“quarter-turn,” i.e., about a 90 degree rotation, it should beunderstood that a wide variety of rotational angles can be employed asdiscussed herein.

In one embodiment, the pump 102 is a syringe pump in which a plunger isincrementally advanced to dispense insulin or other medicament. Suchpumps typically require a cap, such as a screw cap, to be disposed onthe pump at an end of the syringe to prevent unintended dispensing ofinsulin. In the rotational attachment embodiment of the cartridge 116described above, the rotation of the cartridge on attachment enables thecartridge to essentially function as a cartridge and an integrated screwcap to prevent unintended dispensing of insulin, thereby removing theneed for the additional component of the screw cap.

FIGS. 4A-4B and FIGS. 5A-5B depict that in some embodiments a pump suchas pump 802 can be interchangeably used either with attachment portion104 to deliver medicament to an infusion site beneath the pump 102 orwith tubing 144 and a connector 146 to deliver medicament through aninfusion site connector 148 displaced from the pump 102. Pump 102 caninclude a recess 139, more clearly shown in FIG. 3C, that can includeone or both of an opening (not pictured) configured to align with aninsertion site 112 in the retention frame 106 and an opening 152configured to connect to an end connector 154 of tubing 144. Recess 139can also aid in attaching pump 102 to the retention frame 106 asdiscussed with respect to FIGS. 1C-1F. The pump 102 can thereforealternatively be used either with that attachment portion 104 as shownin FIG. 4 or the tubing 144 and infusion site connector 148 as shown inFIG. 5 according to user preference. FIGS. 6A and 6B further illustratethese alternative uses. Pump 102A is depicted as being used with anattachment portion 104 carried directly on the user, whereas pump 102Bis depicted utilizing tubing 144 having an end connector 146 connectingto an infusion site connector 148 attached to the user with the pump102B carried in a separate location, such as in the user's pocket.

FIGS. 7A-7C depict a remote control devices that can be used to controldelivery of medicament and transfer data with a patch pump viaBluetooth, Bluetooth low energy, mobile or Wi-Fi communication, forexample, according to embodiments of the present invention. Such aremote control could include, for example, a dedicated remote controller171 as shown in FIGS. 7B-7C, a mobile communication device 170 such as asmartphone as shown in FIG. 7A, a wearable electronic watch orelectronic health or fitness monitor or a personal digital assistant(PDA), etc. or a tablet, laptop or personal computer.

Referring to FIGS. 7B-7C, a dedicated remote controller 171 according toembodiments of the invention can include a touchscreen display 173.Touchscreen 173 can, in various embodiments, include a color display andbe a capacitive touchscreen, resistive touchscreen, or the like and canbe single touch or multi-touch touchscreen. Dedicated remote controller171 can further include one or more of a touch-sensitive button 175, apush button 177 and a port 179. In some embodiments, touch-sensitivebutton 175 can be configured to return the controller 171 to a homescreen from another menu screen any time the button 175 is touched andthe push button 177 can be configured to wake the device from a sleep oroff mode and activate the display 173 any time the button 177 ispressed. In other embodiments, these functions can be reversed or bothfunctions can be accomplished with a single button depending on thecurrent state of the device. Port 179 can be any type of port known inthe art for data transfer and charging of a rechargeable battery in thecontroller 171, such as, for example, a USB port. Controller 171 canadditionally include one or more of a speaker/microphone, vibratorand/or light, such as an LED light, for providing alerts, alarms,notifications, etc.

FIG. 8 depicts a bolus button 172 located on the pump 102 that can alsobe used to initiate delivery of medicament with pump 102. Because thedepicted patch pump does not itself include a display or user interface,information and feedback regarding dosing initiated with the bolusbutton 172 can be communicated to and displayed on the remote controldevice 170.

In some embodiments, patch pumps as described herein can interface witha glucose meter, such as a blood glucose meter (BGM) or a continuousglucose monitor (CGM), the latter category of which provides asubstantially continuous estimated glucose level through atranscutaneous sensor that measures analytes, such as glucose, in thepatient's interstitial fluid rather than the patient's blood. Patch pumpsystem can use data obtained from a glucose meter such as a CGM toadjust therapy with patch pump either automatically, such as in aclosed-loop or semi-closed loop “artificial pancreas” system, or byproviding such data for user review via a remote control device 170,171. The data may be transmitted from the CGM to the patch pump and/orremote controller via a wireless transmitter, such as a near fieldcommunication (NFC) radio frequency (RF) transmitter or a transmitteroperating according to a “Wi-Fi” or Bluetooth® protocol or the like, orthe data may be transmitted via a wire connector. Further detailregarding CGM systems and definitions of related terms can be found in,e.g., U.S. Pat. Nos. 8,311,749, 7,711,402 and 7,497,827, each of whichis hereby incorporated by reference in its entirety.

FIGS. 9A-9D depict one example of a procedure or method for filling thecartridge 116 of a patch pump system 100 according to an embodiment ofthe present invention. Initially, the cartridge 116—unattached to thedrive unit of the pump—is connected to a disposable plunger 174 and avial adapter 176. As shown in FIG. 9A, the user then pulls outwardly onthe disposable plunger 174 in the direction of the arrow to draw airinto the cartridge 116. The vial adapter 176 is then connected to a vial178 of medicament as shown in FIG. 9B and the disposable plunger isdepressed in the direction of the arrow to expel the air that was drawninto the cartridge 116 into the vial 178. This cartridge fillingassembly is then turned upside down as shown in FIG. 9C and thedisposable plunger 174 is again pulled outwardly in the direction of thearrow to draw medicament from the vial 178 to fill the cartridge. Thevial 178, vial adapter 176 and disposable plunger 174 are thendisconnected from the cartridge 116 and the cartridge 116 is ready to beloaded onto a drive unit 118 of a pump as described herein.

Patch pumps according to embodiments of the present invention caninclude one or more rechargeable batteries in the drive unit. In someembodiments, a rechargeable battery can be inductively charged. FIGS.10A-10E depict a procedure for inductively charging the one or morebatteries of a patch pump according to one embodiment. Such anembodiment includes an inductive charging pad 180 as shown in FIG. 10A.To charge the pump 102, it is removed from attachment with the user'sbody (FIG. 10B) and/or disconnected from the tubing of the infusion set(FIG. 10C). The charging pad 180 can optionally include a cover 182having a cutout sized to receive pump 102 in order to properly positionand retain the pump 102 on the charging pad 180 such as is shown in FIG.10D. The pump 102 can be placed onto the charging pad 180 as shown inFIG. 10E where it will automatically be inductively charged when the pad180 is connected to a power source. In some embodiments, a patch pumpthat can be inductively charged does not include a connection, such as aUSB port, into which a power cord can be inserted for power transfer.Such an embodiment provides the advantages of being more robust forwaterproofing because of the lack of exposed electrical contacts andobviating electrical isolation requirements imposed upon suchconnections.

FIGS. 11A-11E depict one embodiment of a procedure for affixing theattachment portion 104 of a patch pump system to the skin of a user andinserting a cannula into the skin. First, an adhesive backing 107 can beremoved from the adhesive patch 108 holding the retention frame 106 andthe patch applied to the skin at the desired insertion site. Next, acannula inserter 184 is aligned with the insertion portion 112 ofretention frame 106 (see FIGS. 1A-1B) for insertion of a cannula intothe user's skin. Proper alignment can be insured by inserting distallypositioned feet 186 of the inserter 184 into slots in the retentionframe 106 adjacent the insertion portion 112 as shown in FIGS. 11B and11C. In some embodiments, feet 186 can include a hook portion that hooksinto the slots to maintain the position of the feet 186 within slotsduring the insertion process. The inserter 184 is pushed down in thedirection of the arrow as shown in FIG. 11D to insert the cannula 188and then removed leaving the cannula 188 in place on the frame andinserted through the skin as shown in FIG. 11E. FIGS. 12A-12D show asubstantially similar procedure for inserting a cannula into an infusionsite located remotely from the pump such as is shown in FIG. 5A-5B, withan infusion site connector 148 and an infusion site patch 190 used inplace of adhesive patch 107 with retention frame 106. In someembodiments, an audible sound such as a click sounding can indicate thatthe cannula has been properly inserted.

Referring now to FIGS. 13A-13C, a patch pump 202 that can be used withpatch pump systems as described herein according to another embodimentof the invention is depicted. Patch pump 202 is similar to patch pump102 in that cartridge 216 is attached to drive unit 218 by axiallymoving and rotating cartridge 216 with respect to drive unit 818. Asshown in FIGS. 13A-13B, the drive end 223 of the drive mechanism 222 ofthe drive unit 218 is axially inserted into a recess (not pictured) inthe cartridge 216 with the outer front housing surface 240 of thecartridge 216 at an offset, non-parallel angle to the outer fronthousing surface 242 of the drive unit 218 and then the cartridge 216 isrotated to attach and lock the cartridge 216 in place on the drive unit218 with the front surfaces 240, 242 parallel as shown in FIG. 13C. Inthe depicted embodiment, the offset angle between the front surfaces240, 242 at the initial attachment is approximately 60 degrees. The keyaspect of such a rotation is that it enables locking features of thecartridge and drive unit to be initially aligned and then rotated intoengagement with each other to lock the cartridge in place on the driveunit, which can be accomplished with a wide variety of angles in variousembodiments. For example, in certain embodiments, this angle can bebetween about 30 degrees and about 150 degrees.

Also depicted in the embodiment of FIGS. 13A-13C is a short length oftubing 253 and a connector 252. As can be seen in FIGS. 14A and 14B,connector 252 is designed to connect to a connector 254 of an infusionset 245. Infusion set 245 includes a length of tubing 244 extending fromthe connector 254 to a site connector 246 that connects to an infusionsite connector as shown in, e.g., FIGS. 5A-5B to deliver medicament tothe infusion site. In some embodiments, connector 252 extending fromcartridge 216 and connector 254 of infusion set 245 can be Luer Lockconnections.

Further details regarding the connection features of the cartridge 216and the drive unit 218 are shown in FIG. 15 and FIG. 16, respectively.As noted above, cartridge 216 includes a coupling recess 224 into whichdrive end 223 of drive unit 218 is inserted by relative axial motionbetween cartridge 216 and drive unit 218. Referring to FIG. 15,cartridge 216 defines a pair of slots 261 on opposing sides of recess224 and a corresponding flange 260 located axially proximally of eachslot 261 and projecting towards the center of recess 224. A detentgroove 262 is positioned on a surface 263 that defines both a proximalsurface of slot 261 and a distal surface of flange 260. Flange 260further defines a convex stop feature 270. An o-ring 274 can also bepositioned within recess 224 to enhance sealing between and reduce wearand tear on the components. As shown in FIG. 16, drive mechanism 222,shown without drive unit housing for sake of clarity, includes a pair ofthreads or locking wedges 266 configured to mate with the slots 261defined in cartridge 216, as will be discussed in further detail below.Threads 266 each further define a concave stop feature 268 that cancooperate with stop feature 270 of cartridge 216 to ensure properangular alignment of the cartridge 216 and drive unit 218, as will alsobe explained in further detail below. In some embodiments, threads orwedges, which could also be considered flanges, are flexible andelastically deform in order to form a proper connection.

As can be seen in FIGS. 17A-17B, threads 266 on drive mechanism 222 areprovided with a geometry that closes matches the geometry of slots 261in cartridge 216, including a detent projection 264 that matches thedetent groove 262 in slot 261. The geometry of threads 266 differs fromthat of slots 261 in that each thread 266 is a wedge that increases inwidth from a leading edge of the thread 266 defined by the stop feature268 towards the detent projection 264, whereas a width of thecorresponding slot 261 remains generally constant. This narrower leadingportion of the threads 266 enables the threads to easily be initiallyinserted into the slots 261 upon initial rotation of the cartridge 216while providing a secure, compression fit as the wider portions of thethreads 266 are forced into the slots 261 upon further rotation of thecartridge 216 relative to the drive mechanism 222. A curved ramp 272 isproviding on a trailing end of each thread 266 to ease the removal ofthe threads 266 from the slots 261 by rotating the cartridge 216 in theopposite direction.

FIG. 18A depicts the proper angular orientation of cartridge 216 withrespect to drive mechanism 222 for their relative axial movement toinsert coupling recess 224 onto drive end 223, thereby enablingconnection of the cartridge 216 and the drive unit 218. As can be seenin the figure, the threads 266 of drive mechanism 222 are rotationallyoffset from the slots 261 and flanges 260 in the recess 224 of cartridge216. If the threads 266 are not offset, as shown in FIGS. 17A-17B, theflanges 260 would abut the threads 266 upon initial relativecartridge-drive mechanism relative axial movement, preventing furtherrelative axial movement, which in turn prevents insertion of the driveend 223 further into the recess 223. In this manner, the flanges 260serve to ensure proper angular orientation of the cartridge 216 withrespect to the drive unit so to effect a proper connection therebetween.When a proper angular orientation is achieved, the drive mechanism 222is inserted into the recess 223 until the threads 266 have been advancedaxially distal of the flanges 260.

One the threads 266 have been axially aligned with the slots 261, thecartridge 216 can now be rotated relative to drive mechanism 222, in thedirection of the arrow A in FIGS. 18A-18B, to attach the cartridge 216to the drive unit by mating the threads 266 with the slots 261. FIG. 18Bdepicts a thread 266 partially seated within a slot 261 after partialrotation of the cartridge 216 with respect to the drive unit. As can beseen in the figure, the narrower leading edge of thread defined by stopfeature 268 has enabled initial insertion of the thread 266 into theslot 261 and a compression fit has begun to form as the wider portionsof thread 266 are forced into the slot 261. This rotation continuesuntil the detent projections 264 on threads 266 are seated in the detentgrooves 262 in slots 261 as shown in FIG. 18C, at which point thecartridge 216 is aligned flush with drive unit and the cartridge isprevented from further rotation by the leading edge of threads 266abutting the ends 276 of the slots and the detent projections 264 nestedin the detent slots 262. The cartridge 216 cannot be distally moved awayfrom the drive unit by the threads 266 being confined by the slots 261and the flanges 260. Curved ramp portions 272 of threads 266 are alsoheld within slots 261 to retain the cartridge 216 in place, but rotationof the cartridge in the opposite direction of the insertion directionwith a requisite amount of force to slide the detent projections 264 outof the detent grooves 262 will cause curved ramp portions 272 to slideout of slots 216 to enable disengagement of the cartridge 216 from thedrive unit.

FIG. 19 depicts the operation of stop features 268 and 270, whichfunction to ensure that the drive mechanism 222 is inserted to theproper axial depth into recess 224 before the cartridge 216 is rotated.If the drive mechanism 222 is not inserted into the recess 224 such thatthe flanges 260 are advanced axially past the threads 266 to align thethreads 260 with the slots 261, when the cartridge 216 is rotated thestop features 168 at the leading edges of the threads 266 will encounterthe stop features 270 of the flanges 260. This prevents further rotationof the cartridge 216 relative to drive unit 218. The convex matingconfiguration of the stop features 270 of the flanges 260 and concaveconfiguration of the stop features 268 of the threads 266, which, incertain embodiments, can be reversed or shaped differently, ensure thatrepeated contact between these components will not unreasonably stressor wear on the components.

After the cartridge has been installed on the drive unit according tothe embodiments of the invention described herein, the cartridge isretained on the drive unit with sufficient force to minimize anycompliance in the connection. As such, manufacturing tolerances for theflanges features on the disclosed cartridges are such that at theextents of the manufacturing tolerances the flanges flex with enoughforce upon the cartridge being installed onto the drive unit that whenthe drive mechanism is operated to push against a plunger in thecartridge to dispense medicament from the cartridge, there is norelative movement between the cartridge and the drive system. In oneembodiment, the nominal flex or interference of the cartridge flanges isabout 0.010 inches with a range due to tolerance stacking of about 0.006to 0.014 inches. This enables the attachment to be sufficient towithstand force values of approximately 5 to 12 pounds, which in someembodiments is the maximum force output of the drive mechanism andequates to infusion pressures of approximately 20-50 psi. A benefit ofminimizing this compliance is that it decreases the time to detectocclusions that are detected based on the motor stalling and minimizesthe bolus a patient receives if an occlusion in the tubing is cleared tothe pressure increase.

Although the pump system described herein is described as auser-wearable patch pump system that has no display or user interfaceand is primarily controlled by a remote device, it should be understoodthat aspects of the present disclosure can be incorporated into othertypes of infusion pumps. For example, full-featured user-wearableinfusion pumps having display and input capabilities, such as atouchscreen display on the pump housing, such as disclosed in U.S. Pat.No. 8,287,495, which is hereby incorporated by reference herein, canincorporate aspects of the present disclosure.

Also incorporated herein by reference in their entirety are commonlyowned U.S. Pat. Nos. 8,287,495; 8,408,421 8,448,824; 8,573,027;8,650,937; 8,986,523; 9,173,998; 9,180,242; 9,180,243; 9,238,100;9,242,043; and 9,335,910 commonly owned U.S. Patent Publication Nos.2009/0287180; 2012/0123230; 2013/0053816; 2013/0159456; 2013/0324928;2013/0331790; 2013/0332874; 2014/0273042; 2014/0276419; 2014/0276420;2014/0276423; 2014/0276531; 2014/0276537; 2014/0276553; 2014/02765562014/0276569; 2014/0276570; 2014/0276574; 2014/0378898; 2015/0073337;2015/0072613; 2015/0182693; 2015/0182694; 2015/0182695; 2016/0030669;and 2016/0082188 and commonly owned U.S. patent application No.14/707,851 and commonly owned U.S. Provisional Application Ser. Nos.61/911,576; 61/920,902; 61/920,914; 61/920,940; 62/139,275; 62/163,158;62/207,748; 62/256,398; 62/272,255 and 62/300,410.

Further incorporated by reference herein in their entirety are U.S. Pat.Nos. 8,601,465; 8,502,662; 8,452,953; 8,451,230; 8,449,523; 8,444,595;8,343,092; 8,285,328; 8,126,728; 8,117,481; 8,095,123; 7,999,674;7,819,843; 7,782,192; 7,109,878; 6,997,920; 6,979,326; 6,936,029;6,872,200; 6,813,519; 6,641,533; 6,554,798; 6,551,276; 6,295,506; and5,665,065.

Various embodiments of systems, devices, and methods have been describedherein. These embodiments are given only by way of example and are notintended to limit the scope of the claimed inventions. It should beappreciated, moreover, that the various features of the embodiments thathave been described may be combined in various ways to produce numerousadditional embodiments. Moreover, while various materials, dimensions,shapes, configurations and locations, etc. have been described for usewith disclosed embodiments, others besides those disclosed may beutilized without exceeding the scope of the claimed inventions.

Persons of ordinary skill in the relevant arts will recognize that thesubject matter hereof may comprise fewer features than illustrated inany individual embodiment described above. The embodiments describedherein are not meant to be an exhaustive presentation of the ways inwhich the various features of the subject matter hereof may be combined.Accordingly, the embodiments are not mutually exclusive combinations offeatures; rather, the various embodiments can comprise a combination ofdifferent individual features selected from different individualembodiments, as understood by persons of ordinary skill in the art.Moreover, elements described with respect to one embodiment can beimplemented in other embodiments even when not described in suchembodiments unless otherwise noted.

Although a dependent claim may refer in the claims to a specificcombination with one or more other claims, other embodiments can alsoinclude a combination of the dependent claim with the subject matter ofeach other dependent claim or a combination of one or more features withother dependent or independent claims. Such combinations are proposedherein unless it is stated that a specific combination is not intended.

Any incorporation by reference of documents above is limited such thatno subject matter is incorporated that is contrary to the explicitdisclosure herein. Any incorporation by reference of documents above isfurther limited such that no claims included in the documents areincorporated by reference herein. Any incorporation by reference ofdocuments above is yet further limited such that any definitionsprovided in the documents are not incorporated by reference hereinunless expressly included herein.

For purposes of interpreting the claims, it is expressly intended thatthe provisions of 35 U.S.C. § 112(f) are not to be invoked unless thespecific terms “means for” or “step for” are recited in a claim.

1-23. (canceled)
 24. A method of attaching a medicament cartridge to adrive unit of a user-wearable infusion pump, comprising: positioning themedicament cartridge adjacent the drive unit along an axial directionwith the medicament cartridge in a non-parallel orientation with respectto the drive unit; and selectively locking the medicament cartridge intoengagement with the drive unit by rotating the medicament cartridgeabout the axial direction into a generally parallel orientation withrespect to the drive unit.
 25. The method of claim 24, furthercomprising rotating the medicament cartridge to unlock the cartridgefrom the drive unit.
 26. The method of claim 25, wherein selectivelylocking the medicament cartridge by rotating the medicament cartridgeabout the axial direction includes rotating the medicament cartridge ina first direction, and rotating the medicament cartridge to unlock thecartridge includes rotating the medicament cartridge in a seconddirection opposite of the first direction.
 27. The method of claim 24,wherein selectively locking the medicament cartridge by rotating themedicament cartridge about the axial direction includes rotating themedicament cartridge less than 360 degrees.
 28. The method of claim 24,wherein selectively locking the medicament cartridge by rotating themedicament cartridge about the axial direction includes rotating themedicament cartridge less than 180 degrees.
 29. The method of claim 24,wherein selectively locking the medicament cartridge by rotating themedicament cartridge about the axial direction includes rotating themedicament cartridge less than 90 degrees.
 30. The method of claim 24,wherein positioning the medicament cartridge adjacent the drive unitalong an axial direction includes inserting a coupling recess of themedicament cartridge onto a drive end extending from a drive unithousing of the drive unit.
 31. A method of attaching a medicamentcartridge to a drive unit of a user-wearable infusion pump, comprising:positioning a drive end of the drive unit within a coupling recess ofthe medicament cartridge with the medicament cartridge in a non-parallelorientation with respect to the drive unit; and selectively locking themedicament cartridge into engagement with the drive unit by rotating themedicament cartridge about the drive end into a generally parallelorientation with respect to the drive unit.
 32. The method of claim 31,further comprising rotating the medicament cartridge to unlock thecartridge from the drive unit.
 33. The method of claim 32, whereinselectively locking the medicament cartridge by rotating the medicamentcartridge about the drive unit includes rotating the medicamentcartridge in a first direction, and rotating the medicament cartridge tounlock the cartridge includes rotating the medicament cartridge in asecond direction opposite of the first direction.
 34. The method ofclaim 31, wherein selectively locking the medicament cartridge byrotating the medicament cartridge about the drive unit includes rotatingthe medicament cartridge less than 360 degrees.
 35. The method of claim31, wherein selectively locking the medicament cartridge by rotating themedicament cartridge about the drive unit includes rotating themedicament cartridge less than 180 degrees.
 36. The method of claim 31,wherein selectively locking the medicament cartridge by rotating themedicament cartridge about the drive unit includes rotating themedicament cartridge less than 90 degrees.
 37. A method of attaching amedicament cartridge to a drive unit of a user-wearable infusion pump,comprising: positioning the medicament cartridge adjacent the drive unitalong an axial direction with a cartridge housing of the medicamentcartridge in a non-coplanar orientation with respect to a drive unithousing of the drive unit; and selectively locking the medicamentcartridge into engagement with the drive unit by rotating the medicamentcartridge about the axial direction such that the cartridge housing isin a generally coplanar orientation with respect to the drive unithousing.
 38. The method of claim 37, further comprising rotating themedicament cartridge to unlock the cartridge from the drive unit. 39.The method of claim 38, wherein selectively locking the medicamentcartridge by rotating the medicament cartridge about the axial directionincludes rotating the medicament cartridge in a first direction, androtating the medicament cartridge to unlock the cartridge includesrotating the medicament cartridge in a second direction opposite of thefirst direction.
 40. The method of claim 37, wherein selectively lockingthe medicament cartridge by rotating the medicament cartridge about theaxial direction includes rotating the medicament cartridge less than 360degrees.
 41. The method of claim 37, wherein selectively locking themedicament cartridge by rotating the medicament cartridge about theaxial direction includes rotating the medicament cartridge less than 180degrees.
 42. The method of claim 37, wherein selectively locking themedicament cartridge by rotating the medicament cartridge about theaxial direction includes rotating the medicament cartridge less than 90degrees.
 43. The method of claim 37, wherein positioning the medicamentcartridge adjacent the drive unit along an axial direction includesinserting a coupling recess of the cartridge housing onto a drive endextending from the drive unit housing of the drive unit.